Bioequivalence of Empagliflozin and Metformin Given as a Fixed Dose Combination Compared to Single Tablets

Overview[ - collapse ][ - ]

Purpose The primary objective of this trial is to establish bioequivalence of two fixed dose combination (FDC) tablets (containing medium dose empagliflozin/500 mg metformin [Test 1] and low dose empagliflozin/500 mg metformin [Test 2]) and of the single tablets (medium dose empagliflozin tablets + Glucophage® 500 mg tablet [Reference 1] and low dose empagliflozin tablet + Glucophage® 500 mg tablet [Reference 2]) when administered together after a high fat, high caloric meal. The assessment of safety and tolerability will be an additional objective of this trial.
ConditionHealthy
InterventionDrug: empagliflozin
Drug: metformin (Glucophage®)
Drug: metformin (Glucophage®)
Drug: empagliflozin
Drug: empagliflozin and metformin
Drug: empagliflozin and metformin
PhasePhase 1
SponsorBoehringer Ingelheim
Responsible PartyBoehringer Ingelheim
ClinicalTrials.gov IdentifierNCT01844531
First ReceivedApril 29, 2013
Last UpdatedDecember 11, 2013
Last verifiedDecember 2013

Tracking Information[ + expand ][ + ]

First Received DateApril 29, 2013
Last Updated DateDecember 11, 2013
Start DateApril 2013
Estimated Primary Completion DateNovember 2013
Current Primary Outcome Measures
  • AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [Time Frame: up to 72 hours after drug intake] [Designated as safety issue: No]
  • Cmax (maximum measured concentration of the analyte in plasma) [Time Frame: up to 72 hours after drug intake] [Designated as safety issue: No]
Current Secondary Outcome MeasuresAUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) [Time Frame: up to 72 hours after drug intake] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleBioequivalence of Empagliflozin and Metformin Given as a Fixed Dose Combination Compared to Single Tablets
Official TitleBioequivalence of Empagliflozin/Metformin (500 mg) Fixed Dose Combination Tablets Compared to Single Tablets Administered Together in Healthy Male and Female Volunteers Under Fed Conditions (an Open-label, Randomised, Single-dose, Four-way Crossover Study)
Brief Summary
The primary objective of this trial is to establish bioequivalence of two fixed dose
combination (FDC) tablets (containing medium dose empagliflozin/500 mg metformin [Test 1]
and low dose empagliflozin/500 mg metformin [Test 2]) and of the single tablets (medium dose
empagliflozin tablets + Glucophage® 500 mg tablet [Reference 1] and low dose empagliflozin
tablet + Glucophage® 500 mg tablet [Reference 2]) when administered together after a high
fat, high caloric meal.

The assessment of safety and tolerability will be an additional objective of this trial.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 1
Study DesignAllocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionHealthy
InterventionDrug: empagliflozin
single tablet empagliflozin
Drug: metformin (Glucophage®)
single tablet metformin
Drug: metformin (Glucophage®)
single tablet metformin
Drug: empagliflozin
single tablet empagliflozin
Drug: empagliflozin and metformin
FDC tablet empagliflozin and metformin
Drug: empagliflozin and metformin
FDC tablet empagliflozin and metformin
Study Arm (s)
  • Experimental: FDC empagliflozin dose 1 and metformin
    fix dose combination tablet after intake of a high fat, high caloric meal
  • Active Comparator: empagliflozin dose 1 + metformin tablets
    single tablets after intake of a high fat, high caloric meal
  • Experimental: FDC empagliflozin dose 2 and metformin
    fix dose combination tablet after intake of a high fat, high caloric meal
  • Active Comparator: empagliflozin dose 2 + metformin tablets
    single tablets after intake of a high fat, high caloric meal

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment24
Estimated Completion DateNovember 2013
Estimated Primary Completion DateNovember 2013
Eligibility Criteria
Inclusion criteria:

1. Healthy male and female subjects

2. Subjects must be able to understand and comply with study requirements

3. Age 18 to 50 years

4. Body mass index (BMI) 18.5 to 29.9 kg/m2

Exclusion criteria:

1. Any relevant deviation from healthy conditions
GenderBoth
Ages18 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesGermany

Administrative Information[ + expand ][ + ]

NCT Number NCT01844531
Other Study ID Numbers1276.6
Has Data Monitoring CommitteeNot Provided
Information Provided ByBoehringer Ingelheim
Study SponsorBoehringer Ingelheim
CollaboratorsNot Provided
Investigators Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Verification DateDecember 2013

Locations[ + expand ][ + ]

1276.6.1 Boehringer Ingelheim Investigational Site
Biberach, Germany